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Panels › General, Plastic Surgery › Product code LZK · Class 2

Implant, Malar

Regulation 878.3550

0510(k)s in 12 months (40 all time)

1recalls in 12 months (4 all time)

4recalls that name a 510(k)

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Top companies in LZK

Company	510(k)s	Recalls
Implantech Associates, Inc.	11	0
Spectrum Designs, Inc.	6	3
Byron Medical	3	0
Ceramed Corp.	2	0
Cui Corp.	2	0
King & Spalding	2	0
Surgical Technology Laboratories, Inc.	2	0
Aesthetech Corp.	1	0
Aesthetic and Reconstructive Technologies, Inc.	1	0
Allied Biomedical Corp.	1	0

Date	Firm and product	Code	Linked 510(k)
Dec 18, 2025	DSAART LLC Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI- Open, Classified	LZK	K021419
Aug 29, 2007	Spectrum Designs Inc Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S. Terminated	LZK	K944165
Jul 24, 2007	Spectrum Designs Inc Spectrum Designs Medical Anatomical Chin Implant; Catalog Number 250-134S; Lot # 31140; Serial Numbers BAHO45 through BAH144 Terminated	LZK	K944164
Jul 24, 2007	Spectrum Designs Inc Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655 Terminated	LZK	K944166

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